RecruitingPhase 3NCT07011719

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Sponsor

Arcus Biosciences, Inc.

Enrollment

720 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Clear Cell Renal Cell Carcinoma Advanced Clear Cell Renal Cell Carcinoma

Summary

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding casdatifan (a drug that cuts off the oxygen supply tumors need to grow) to cabozantinib (an existing standard targeted therapy) works better than cabozantinib alone for patients with advanced clear cell kidney cancer. **You may be eligible if...** - You have advanced kidney cancer that cannot be surgically removed, specifically the clear cell type - You have at least one measurable tumor on a CT or MRI scan - You are in good physical condition (Karnofsky score 80% or above) - Women of childbearing potential must have a negative pregnancy test **You may NOT be eligible if...** - You have received prior treatment with cabozantinib or another specific type of targeted therapy for kidney cancer - You have active brain metastases - You have significant heart or blood pressure problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCasdatifan

Administered as specified in the treatment arm

DRUGCabozantinib

Administered as specified in the treatment arm

DRUGPlacebo

Administered as specified in the treatment arm

Locations(44)

City of Hope - Phoenix Cancer Center

Goodyear, Arizona, United States

Mayo Clinic - Phoenix

Phoenix, Arizona, United States

City Of Hope National Medical Center

Duarte, California, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

UCLA Hematology Oncology - 100 Med Plaza

Los Angeles, California, United States

University of California San Diego Moores Cancer Center

San Diego, California, United States

Yale University

New Haven, Connecticut, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Piedmont Cancer Institute OneOncology

Atlanta, Georgia, United States

Emory University - Atlanta

Atlanta, Georgia, United States

City of Hope Cancer Center Atlanta

Newnan, Georgia, United States

City of Hope - Chicago Cancer Center

Zion, Illinois, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Norton Cancer Institute PARENT

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

The University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Rochester Medical Center

Rochester, New York, United States

UNC Hospitals

Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Compass Oncology, OR

Portland, Oregon, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt

Nashville, Tennessee, United States

Texas Tech University Health Science Center

Lubbock, Texas, United States

The University of Utah - Huntsman Cancer Institute (HCI)

Salt Lake City, Utah, United States

CHU Brest - Hôpital Morvan

Brest, France

Hopital Saint Eloi

Montpellier, France

Institut Gustave Roussy

Villejuif, France

Krankenhaus Nordwest GmbH

Frankfurt, Germany

Universitaetsklinikum Halle (Saale)

Halle, Germany

Universitaetsmedizin Rostock

Rostock, Germany

Radboudumc

Nijmegen, Netherlands

Isala

Zwolle, Netherlands

Pratia MCM Krakow

Krakow, Poland

S.C. Sigmedical Services SRL

Suceava, Romania

S.C Oncomed S.R.L

Timișoara, Romania

CHA Bundang Medical Center, CHA University

Seongnam, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Clinic de Barcelona

Barcelona, Spain

Royal Devon and Exeter Hospital (Wonford)

Exeter, United Kingdom

Barts Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07011719

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